Webinar on Medical Devices Software – Watch the replay!

 In Event

DDR and partner CN Group co-organised an informative session on development and Regulation of Medical Device Software (MDSW). The webinar covered the main considerations to keep in mind when developing a MDSW under the new Medical Devices Regulation (MDR).

Watch the replay HERE

If the implementation of the new European Medical Devices and In Vitro Devices Regulations (respectively MDR and IVDR) is complex for most device manufacturers, it is particularly challenging for Medical Devices Software (MDSW) developers. The recent but considerable emergence of MDSW led to their integration into the new regulations, implying significant changes in their development, classification and registration.

During this webinar, CN Group and DDR will first define the main stages of device development, from idea to regulatory strategy, to properly develop a Medical Device Software (MDSW) under the new MDR. Moreover, the speakers will discuss in detail two case studies on existing MDSWs to further illustrate all the concepts developed during the session.

At the end of the presentation, you will have the opportunity to ask your questions and share you thoughts directly with the main speakers Milan Piskla (.NET / CAD / C++ Technology Director, CN Group), Andrea Larrañaga (Regulatory Manager, DDR) and Laura Ocaña (Regulatory Officer, DDR) during a 15min Q&A session.

Total duration 1 hourOctober 14th, 2021 – 04PM CET/03PM BST/10AM EDT

About CN Group (Czech Republic, Slovak Republic, Romania)

For over 27 years, CN Group has been providing high quality IT Software Development and Consulting services to their partners in Scandinavia, Germany, Austria, Switzerland and the UK.Throughout their quarter century history, CN Group guiding principle has been Continuous Improvement. The Group knowledge, experience, skills and services extend far beyond the technologies implemented.

More information: fazik@cngroup.dk | www.cngroup.dk

About DDR (Spain, United Kingdom and The Netherlands)

Independent Regulatory consultancy company, focused in providing appropriate scientific & regulatory expertise for the global development and registration of Drugs and Medical Technologies. DDR identifies fast and cost-efficient strategies to get your products successfully authorised by Regulatory Agencies (quality, nonclinical, clinical & regulatory expertise).

More information: info@ddrmedic.com | www.ddrmedic.com

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